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CTRI Number  CTRI/2025/09/093955 [Registered on: 01/09/2025] Trial Registered Prospectively
Last Modified On: 03/04/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Compare Hemodynamic Profile Of Intrathecal Hyperbaric Bupivacaine 0.5 percent Versus Hyperbaric Levobupivacaine 0.5 percent in Elderly Population Undergoing Infraumbilical Surgeries  
Scientific Title of Study   Randomized Double Blind Study To Compare Hemodynamic Profile Of Intrathecal Hyperbaric Bupivacaine 0.5 percent Versus Hyperbaric Levobupivacaine 0.5 percent in Elderly Population Undergoing Infraumbilical Surgeries. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Prithvi Dupare 
Designation  Junior Resident 
Affiliation  BHARATI VIDYAPEETH (DEEMED TO BE UNIVERSITY) MEDICAL COLLEGE, PUNE, MAHARASHTRA. 
Address  Department of Anaesthesiology Bharati Vidyapeeth(Deemed to be university),Pune

Amravati
MAHARASHTRA
411043
India 
Phone  7057870827  
Fax    
Email  prithvidupare95@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Shubhada S Aphale 
Designation  Professor, Department of Anaesthesiology 
Affiliation  Bharati Vidyapeeth (Deemed to be university)Medical college,Pune. 
Address  Department of Anaesthesiology, Bharati Vidyapeeth (Deemed to be university)Medical college,Satara Rd, Dhankawadi, Pune, Maharashtra 411043

Pune
MAHARASHTRA
411043
India 
Phone  9850968630  
Fax    
Email  subhada.aphale@yahoo.com  
 
Details of Contact Person
Public Query  
Name  Shubhada S Aphale 
Designation  Professor, Department of Anaesthesiology 
Affiliation  Bharati Vidyapeeth (Deemed to be university)Medical college,Pune. 
Address  Department of Anaesthesiology, Bharati Vidyapeeth (Deemed to be university)Medical college,Satara Rd, Dhankawadi, Pune, Maharashtra 411043

Pune
MAHARASHTRA
411043
India 
Phone  9850968630  
Fax    
Email  subhada.aphale@yahoo.com  
 
Source of Monetary or Material Support  
Bharati Hospital and Research Centre, Pune-Satara Road, Pune-411043, Maharashtra, India  
 
Primary Sponsor  
Name  Bharati Hospital and Research Centre, Pune 
Address  Bharati Hospital and Research Centre, Pune-Satara Road, Pune-411043, Maharashtra, India . 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Prithvi Dupare  Bharati Hospital and Research Centre, Pune  Bharati Hospital and Research Centre, Satara Road, Pune
Pune
MAHARASHTRA 		 7057870827

prithvidupare95@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
BHARATI VIDYAPEETH MEDICAL COLLEGE INSTITUTIONAL ETHICS COMMITTEE   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Inj Bupivacaine 0.5 percent heavy 3.2 ml given intrathecally once prior to surgery  Inj Bupivacaine 0.5 percent Heavy refers to a 0.5 percent solution of bupivacaine that is "heavy" or hyperbaric—meaning it is mixed with glucose (usually 8percent) to make it denser than cerebrospinal fluid (CSF). This property is mainly used for spinal anesthesia. Key details: Concentration: 0.5 percent = 5 mg/mL of bupivacaine Heavy/hyperbaric: Contains glucose to increase density, allowing the anesthetic to settle in specific spinal segments depending on patient positioning. Dose: 3.2 ml Frequency: Once prior to surgery Route: Route is Intrathecal. Intrathecal (spinal) injection, used for surgeries below the umbilicus (e.g., lower limb, lower abdomen, cesarean sections). Onset: Rapid, usually 5-10 minutes Duration: Usually 90–150 minutes depending on dose and patient factors Effect: Provides dense sensory and motor block 
Comparator Agent  Inj Levobupivacaine 0.5 percent Heavy   Inj Levobupivacaine 0.5 percent Heavy is very similar to bupivacaine but is the S enantiomer of bupivacaine, often preferred because it tends to have less cardiotoxicity and neurotoxicity. Concentration: 0.5 percent = 5 mg/mL levobupivacaine Heavy/Hyperbaric: Contains added glucose (usually 8 percent) to make the solution denser than cerebrospinal fluid (CSF), useful for spinal anesthesia. Dose:3.2 ml Frequency: once prior to surgery Route: Route is Intrathecal.Intrathecal (spinal) injection Onset: 5-10 minutes Duration: Typically 2–3 hours, providing long-lasting sensory and motor block Effect: Provides good sensory anesthesia with motor block, suitable for surgeries below the umbilicus 
 
Inclusion Criteria  
Age From  60.00 Year(s)
Age To  90.00 Year(s)
Gender  Both 
Details  1.Patients with ASA grade II,III.
2.Patient undergoing elective infra umbilical surgeries in supine position under Spinal anesthesia.
 
 
ExclusionCriteria 
Details   
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
To compare hemodynamic parameters(SBP/DBP/MAP) of intrathecal hyperbaric Bupivacaine 0.5 percent with hyperbaric Levobupivacaine 0.5 percent post spinal anaesthesia in ASA II and III elderly population undergoing infraumbilical surgeries.  From 1 minute of administration of spinal anaesthesia till one hour  
 
Secondary Outcome  
Outcome  TimePoints 
To campare requirement of vasopressor between two groups  From 1 minutes of spinal anaesthesia till end of surgery  
To compare Duration of analgesia between the two groups  From 1 minute of spinal anaesthesia till 1 day 
 
Target Sample Size   Total Sample Size="90"
Sample Size from India="90" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 1 
Date of First Enrollment (India)   10/09/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  10/09/2025 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details
Modification(s)  		 N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - For individual participant data meta-analysis.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [prithvidupare95@gmail.com].

  6. For how long will this data be available start date provided 14-10-2026 and end date provided 08-05-2028?
    Response - Beginning 9 months and ending 36 months following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - No
Brief Summary
Modification(s)  		 Spinal anaesthesia has been a popular anaesthesia technique. Hyperbaric
racemic bupivacaine is commonly used for spinal anaesthesia due to its
long duration of action and combined motor and sensory blockade.
However, the use of hyperbaric racemic bupivacaine in spinal anaesthesia
has some drawbacks. It has a high propensity to cause hypotension and
bradycardia following intrathecal injection and there is likely potential
for cardiac toxicity due to the high affinity of bupivacaine to cardiac
myocytes.
Levobupivacaine has a lower affinity for cardiac sodium channels and
greater plasma protein binding affinity compared with the dextro isomer
so reducing the risk of cardio-toxicity and decreasing the incidence of
hypotension and bradycardia.
Levobupivacaine also results in earlier motor recovery compared with
bupivacaine and also has less central nervous system toxicity.
These advantages make Levobupivacaine an safer alternative to
bupivacaine for spinal anaesthesia in high risk and elderly population.
It is currently known that levobupivacaine and bupivacaine have similar
analgesic potentials for Central Neuroaxial block and Peripheral Nerve
block.

 
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